Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05113485

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Diabetes Prevention Program-based lifestyle change intervention (DPP)

Highly Microbiota-Accessible Foods (HMAFs) intervention

Study Details

Brief summary:

Pilot randomized controlled parallel group behavior change comparative effectiveness trial involves 30 breast cancer survivors interested in losing excess body fat. Both interventions include dietary + exercise prescriptions that hold promise for reducing the survivors' risk of cancer recurrence. Both interventions are consistent with the Dietary Guidelines for Americans but the Diabetes Prevention Program (DPP)-based approach focuses on weight loss through calorie restriction and increased physical activity while the Highly Microbiota-Accessible Foods (HMAFs) approach is intended to be a low-numeracy version of a Mediterranean-style diet and increased physical activity. The DPP approach is considered to be a high-numeracy intervention because it requires that consumers keep track of all calories consumed and expended per day and to endeavor to maintain a calorie deficit each day during the active weight loss phase. For both conditions, the 12 to 13-week intervention includes 2 virtual home visits, 2 virtual group education sessions and 7 telephone or Zoom-based coaching sessions by well-trained intervenors. Assessments occur at baseline and six months, with systemic inflammation (high sensitivity C-reactive protein) being the primary outcome measure and visceral fat being a secondary outcome. Other prespecified secondary outcomes include gut microbiota alpha-1 diversity, insulin resistance, HDL-cholesterol, daily count of highly microbiota-accessible foods, waist circumference, BMI, systolic blood pressure, ratio of fecal Proteobacteria to short chain fatty acid-generating bacteria and health-related quality of life.

Conditions

Breast Cancer

Study ID

NCT05113485

Start date

Apr 1, 2022

Status verified date

Apr, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least 6 months since breast cancer diagnosis and up to 4 years since diagnosis.
2. Between 50 and 75 years of age.
3. Diagnosed with localized steroid hormone receptor-positive breast cancer, up to stage IIIa.
4. At least 6 months post chemotherapy or radiation treatment.
5. Subjects must be in good health as determined by medical history, physical examination, and clinical laboratory measurements.
6. No broad-spectrum antibiotic use in the last two months.
7. Body mass index between 27 and 38 based on self-reported height and weight and between 25 and 40 based on objective assessment of height and weight.
8. Willing to complete assessments at baseline, 3 months and 6 months follow-up

Exclusion Criteria:

1. Diagnosed with metastatic breast cancer
2. Currently undergoing chemotherapy or radiation treatment
3. Immunoglobulin-E (IgE)-mediated food allergies, or any medical condition requiring mandatory dietary restrictions
4. Significant cardiac, pulmonary, renal, liver or psychiatric disease.
5. Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Diabetes Prevention Program-based lifestyle change intervention (DPP)

The Diabetes Prevention Program-based lifestyle change intervention (DPP) is designed to help overweight breast cancer survivors to reduce their risk of breast cancer recurrence by reducing their excess body fat.

experimental: Highly Microbiota-Accessible Foods (HMAFs) intervention

The Highly Microbiota-Accessible Foods (HMAFs) lifestyle change intervention is designed to help overweight breast cancer survivors reduce their risk of breast cancer recurrence by reducing their elevated low-grade inflammation.

Interventions

Diabetes Prevention Program-based lifestyle change intervention (DPP)

The DPP condition consists of 11 health education sessions over 12 weeks, including 2 virtual home visits, two virtual group education sessions and 7 telephone coaching calls. These sessions will teach DPP-based lessons on how to lose excess body fat through calorie restriction and increased physical activity. All dietary and physical activity recommendations are intended to be consistent with federal nutrition and physical activity guidelines.

Highly Microbiota-Accessible Foods (HMAFs) intervention

The Highly Microbiota-Accessible Foods (HMAFs) intervention approach includes 11 health education sessions, including two virtual home visits, two virtual group education sessions, and 7 telephone coaching sessions. These sessions are designed to help study participants to identify and consume optimally 6 daily instances of minimally processed, fiber-rich food sources, drawn from all four of the MyPlate.gov categories: vegetables, fruits, whole grains and plant-based protein-rich foods (e.g., legumes, nuts and seeds). Increased physical activity is also recommended as a way to optimize the microbial conversion of fiber-rich food sources to short chain fatty acids, which are then expected to reduce excess low-grade inflammation.

Primary outcome measure

  • High-sensitivity C-Reactive Protein (CRP) [ Time Frame: Change from baseline to 6 months follow-up ]

Central Contacts and Locations

Central contacts

William J. McCarthy, Ph.D.

3107947587wmccarth@ucla.edu

Locations

UCLA Center for Cancer Prevention & Control Research

Recruiting

Los Angeles, California, United States, 90095-6900

Contacts

Jacqueline Wong, B.A.

310-794-9320jcwong@ucla.edu

Principal Investigator:

William J McCarthy, Ph.D.

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 11, 2022

Last verified

Apr, 2022

Keywords

  • obesity
  • physical activity
  • fiber diversity
  • calorie restriction
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2022-04-11.